PregnancyPhase 4PREMEVANCT00642980
Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis
A Phase 4 study testing Clindamycin in people with Pregnancy, run by University Hospital, Lille at 1 site in France.
Trial summary
Background. Anomalies of the vaginal flora (bacterial vaginosis, BV) are associated with an increased risk of late abortions and preterm birth. Studies of antibiotic treatment of BV to reduce the risk of prematurity have not found a statistically significant diminution of risk (<= 32 wks: OR=0.49 [0.05-5.1], < 37 wks… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Clindamycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,105 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2006to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nugent score >= 7
- pregnant women < 15 weeks (strictly)
- signed informed consent
- >=18 old
- speaking and understanding French language
Who cannot join
- metrorrhagias during 7 days before
- birth anticipated in an other area
- clindamycin allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Multicenter Trial for the Prevention of Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis in the First Trimester of Pregnancy
Background. Anomalies of the vaginal flora (bacterial vaginosis, BV) are associated with an increased risk of late abortions and preterm birth. Studies of antibiotic treatment of BV to reduce the risk of prematurity have not found a statistically significant diminution of risk (<= 32 wks: OR=0.49 [0.05-5.1], < 37 wks: OR=0.83 [0.59-1.17]).A partial explanation of these findings is that some of these treatment were administered vaginally, most often during the second or third trimester
Aim: To reduce the frequency of late abortions and very preterm birth by prescribing clindamycin vs placebo to patients diagnosed with BV before 13 weeks.
Read the detailed description
Patients diagnosed with BV before 13 weeks will be divided into two groups. They will be defined as at low risk when they have no history of spontaneous preterm delivery or late abortion. Women with such histories will be defined as at high risk.
Low risk patients will be asked to participate in a trial with 3 equal parallel groups, comparing two regimes of clindamycin (one or three 4-day treatments of clindamycin 300 mgx2/d) and placebo.
High-risk patients will be asked to participate in a trial with 2 parallel groups to assess the usefulness of repeating antibiotic treatment monthly by comparing the administration of one 4-day treatment of clindamycin (300 mgx2/d) to three 4-day treatments, one month apart.
- Conditions
- Pregnancy
- Being tested
- Clindamycin, Placebo
- Keywords
- Pregnancy, Preterm delivery, Bacterial vaginosis, Randomized Clinical Trial, Clindamycin
- Medical subject headings
- Premature Birth, Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClindamycinDrug
Also called non applicable
300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: three times a month apart
PlaceboDrug
Also called non applicable
Double blinded capsules(per os) Intervention= 2 capsules/d during 4 days: three times a month apart
ClindamycinDrug
Also called non applicable
300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: one time and then, after one month placebo capsules 2 capsules/d during 4 days: two times a month apart
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin Cure 1 | Active comparator | Arm 1 Receives: Drug: Clindamycin |
| Clindamycin Cure 2 | Active comparator | Arm 2 Receives: Drug: Clindamycin |
| Placebo | Placebo comparator | Arm placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature delivery (16 to 32 weeks of gestation)
Measured: At delivery
Secondary outcomes (1)
Preterm labor, PPROM, Spontaneous preterm labor, PROM, Abruptio placentae, Chorioamnionitis, Fever > 38°C during labor, Post partum fever (> 38°), Post-partum wound infections, Perinatal death, NICU transfer, Bacterial neonatal colonisation.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startApr 2006
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Damien SUBTIL, MD PhD, Principal investigator, University Hospital, Lille (France)Gilles Brabant, MD, Study chair, Groupe Hospitalier de l' Institut Catholique, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642980
- Sponsor's protocol ID
- 060216
- Other IDs
- PHRC 2004/1918, PHRC 2008/1929, 2004/0428
- Acronym
- PREMEVA
- Status last verified
- Jan 2008
- First submitted
- 21 Mar 2008
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Subtil D, Brabant G, Tilloy E, Devos P, Canis F, Fruchart A, Bissinger MC, Dugimont JC, Nolf C, Hacot C, Gautier S, Chantrel J, Jousse M, Desseauve D, Plennevaux JL, Delaeter C, Deghilage S, Personne A, Joyez E, Guinard E, Kipnis E, Faure K, Grandbastien B, Ancel PY, Goffinet F, Dessein R. Early clindamycin for bacterial vaginosis in pregnancy (PREMEVA): a multicentre, double-blind, randomised controlled trial. Lancet. 2018 Nov 17;392(10160):2171-2179. doi: 10.1016/S0140-6736(18)31617-9. Epub 2018 Oct 12.
PubMed 30322724
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Trial for the Prevention of Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis in the First Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT00642980
- Acronym / sponsor ID
- PREMEVA / 060216
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Preterm delivery, Bacterial vaginosis, Randomized Clinical Trial, Clindamycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,105 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background. Anomalies of the vaginal flora (bacterial vaginosis, BV) are associated with an increased risk of late abortions and preterm birth. Studies of antibiotic treatment of BV to reduce the risk of prematurity have not found a statistically significant diminution of risk (<= 32 wks: OR=0.49 [0.05-5.1], < 37 wks: OR=0.83 [0.59-1.17]).A partial explanation of these findings is that some of these treatment were administered vaginally, most often during the second or third trimester
Aim: To reduce the frequency of late abortions and very preterm birth by prescribing clindamycin vs placebo to patients diagnosed with BV before 13 weeks.
Detailed description
Patients diagnosed with BV before 13 weeks will be divided into two groups. They will be defined as at low risk when they have no history of spontaneous preterm delivery or late abortion. Women with such histories will be defined as at high risk.
Low risk patients will be asked to participate in a trial with 3 equal parallel groups, comparing two regimes of clindamycin (one or three 4-day treatments of clindamycin 300 mgx2/d) and placebo.
High-risk patients will be asked to participate in a trial with 2 parallel groups to assess the usefulness of repeating antibiotic treatment monthly by comparing the administration of one 4-day treatment of clindamycin (300 mgx2/d) to three 4-day treatments, one month apart.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clindamycin Cure 1 | Active comparator | Drug: ClindamycinArm 1 |
| Clindamycin Cure 2 | Active comparator | Drug: ClindamycinArm 2 |
| Placebo | Placebo comparator | Drug: PlaceboArm placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Nugent score >= 7
- pregnant women < 15 weeks (strictly)
- signed informed consent
- >=18 old
- speaking and understanding French language
Key exclusion criteria (3 listed)
- metrorrhagias during 7 days before
- birth anticipated in an other area
- clindamycin allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClindamycinAlso: non applicable300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: three times a month apart | Drug | Clindamycin Cure 1 |
| PlaceboAlso: non applicableDouble blinded capsules(per os) Intervention= 2 capsules/d during 4 days: three times a month apart | Drug | Placebo |
| ClindamycinAlso: non applicable300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: one time and then, after one month placebo capsules 2 capsules/d during 4 days: two times a month apart | Drug | Clindamycin Cure 2 |
Primary outcome
Premature delivery (16 to 32 weeks of gestation)
Time frame: At delivery
1 secondary outcome
Preterm labor, PPROM, Spontaneous preterm labor, PROM, Abruptio placentae, Chorioamnionitis, Fever > 38°C during labor, Post partum fever (> 38°), Post-partum wound infections, Perinatal death, NICU transfer, Bacterial neonatal colonisation.
Time frame: At delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Results publication: PubMed 30322724Subtil D, Brabant G, Tilloy E, Devos P, Canis F, Fruchart A, Bissinger MC, Dugimont JC, Nolf C, Hacot C, Gautier S, Chantrel J, Jousse M, Desseauve D, Plennevaux JL, Delaeter C, Deghilage S, Personne A, Joyez E, Guinard E, Kipnis E, Faure K, Grandbastien B, Ancel PY, Goffinet F, Dessein R. Early clindamycin for bacterial vaginosis in pregnancy (PREMEVA): a multicentre, double-blind, randomised controlled trial. Lancet. 2018 Nov 17;392(10160):2171-2179. doi: 10.1016/S0140-6736(18)31617-9. Epub 2018 Oct 12.
- Website of the study (for patients and all kinds of public)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damien SUBTIL, MD PhD principal investigator
University Hospital, Lille (France)
Gilles Brabant, MD study chair
Groupe Hospitalier de l' Institut Catholique, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clindamycin in people with Pregnancy, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premature delivery (16 to 32 weeks of gestation) (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00642980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.